Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention

C

Case Western Reserve University

Status

Completed

Conditions

Asthma

Treatments

Behavioral: Family Education Intervention
Behavioral: Tailored Problem Solving Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00149487
R01HL069547 (U.S. NIH Grant/Contract)
257

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of a tailored problem solving intervention in increasing adherence to asthma management behaviors in African American adolescents with asthma.

Full description

BACKGROUND: Children and adolescents who are unable to adhere to their medical regimen for the management of chronic illness present considerable challenges to health care providers and researchers. Pediatric asthma is a chronic illness where the consequences of non-adherence are particularly detrimental and widespread, especially among economically disadvantaged minority children and their families. Studies of intervention of asthma management are needed for this population. DESIGN NARRATIVE: The aim of the proposed study is to test the efficacy of a problem solving intervention that is tailored to the observed adherence behaviors and identified barriers to increasing adherence in African American children and adolescents with asthma, and their families. Patients are randomized to either a Tailored Problem Solving Intervention, or a control group who will receive Family Education Intervention. Duration of the intervention is four months.

Enrollment

120 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • African American
  • Family income to be below the poverty line
  • Physician-based diagnosis of asthma of at least 12 months
  • Moderate to severe asthma (moderate asthma includes daily symptoms, daily use of inhaled short acting beta-agonist, exacerbations greater than 2 times per week that affect activity, and nighttime symptoms greater than once a week, FEV1 or Peak Flow PEF between 60 and 80 percent predicted and PEF variability greater than 30 percent; severe asthma includes continual symptoms, limited physical activity, frequent exacerbations together with frequent nighttime symptoms, FEV1 or PEF less than 60 percent predicted, and PEF variability greater than 30 percent)
  • Likely to be on a stable and daily medication (inhaled steroid) that can be modified electronically for the time period required to participate in the study

Exclusion criteria

Presence of a serious comorbid chronic condition

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Experimental: Tailored Problem Solving Intervention
Experimental group
Description:
Participants will be randomized to follow a tailored problem solving intervention for the child.
Treatment:
Behavioral: Tailored Problem Solving Intervention
Behavioral: Family Education Intervention
Control: Family Education Intervention
Active Comparator group
Description:
Participants will be randomized to follow a family education intervention.
Treatment:
Behavioral: Tailored Problem Solving Intervention
Behavioral: Family Education Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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